Text Messaging and Cognitive Behavioral Therapy for Depression (HealthySMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01083628|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Group CBT for Depression with MoodText Behavioral: Group CBT for Depression||Not Applicable|
Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy.
Objectives: The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, the investigators aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients.
Methods: Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Automated Text Messaging to Increase Engagement in Cognitive Behavioral Therapy (CBT) for Depression|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||April 2017|
Experimental: Group CBT for Depression with MoodText'
Group cognitive behavioral therapy utilizing the BRIGHT manual for depression along with automated text messaging for mood monitoring and reminder of session content
Behavioral: Group CBT for Depression with MoodText
Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
Other Name: Group CBT for Depression with HealthySMS
Active Comparator: Group CBT for Depression
Standard group cognitive behavioral therapy utilizing the BRIGHT manual for depression
Behavioral: Group CBT for Depression
Standard group CBT for depression using BRIGHT manual
- PHQ-9 Depression Symptoms [ Time Frame: 16 weeks ]The PHQ-9 (Patient Health Questionnaire - 9) is commonly used to screen for depression and to monitor progression of depressive symptoms over time. The scores represent the following depression severity: 0-4: minimal depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe, 20-27: severe. A score of 10 is often recommended as the cut-off score for diagnosing an episode of depression that may require treatment.
- Attendance [ Time Frame: 16 weeks ]Number of sessions attended
- Duration of Therapy Attended [ Time Frame: 16 weeks ]Number of weeks until patients dropped out of therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083628
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Adrian Aguilera, Ph.D.||University of California, San Francisco|